Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 3: Investigator’s Responsibilities: Investigator Initiated Trials (2019)


Topics

  1. Topics
    1. Form 1572
    2. 21 CFR 312.50
  2. What is FDA form 1572?
    1. Statement of Investigator
  3. When don’t we use the 1572?
    1. Investigation Device Studies
    2. Non-IND Studies
  4. Why does the Investigator need to fill it out?
    1. Dual Purpose 
  5. FDA Form 1572 and FAQs
    1. Guidance for sponsors, investigators and IRBs
  6. 1572 Commitments
  7. When to sign the 1572?
  8. The “Legal” Part
  9. 1572 Commitments
  10. Statement of Investigator
  11. Binding Agreement
  12. Helpful Reference!
  13. 21 CFR 312.50
    1. General responsibilities of sponsors

Acknowledgement

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu


Instructors

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.